Without limiting the scope of the invention, its background is described in connection with the removal and re-insertion of autologous cells during reconstructive surgery.
Liposuction is a procedure for removing fatty tissue from the body in which a cannula is inserted and fatty tissue is removed by moving the cannula back and forth. Generally, the cannula is attached to a syringe or a vacuum pump that provide suction to remove broken-up fatty tissue. Liposuction devices are designed typically to withstand the temperatures and pressures of autoclaves for reuse in multiple procedures. Liposuction devices capable of multiple uses, however, increase greatly the unit cost. An alternative is to prepare single-use, disposable liposuction units.
A problem with the prior art is that these devices tend to generate large amounts of unusable material as the fatty tissue undergoes multiple-processes steps prior to re-introduction back into the host at an alternative site, e.g., during reconstructive surgery. The advantage of re-introducing autologous fatty tissue is that it reduces greatly or eliminates rejection of the tissue. Fatty tissue degradation is the result of a number of factors including, e.g., the delicate nature of the cells, the mechanical removal of the cells, the multiple step process used to separate viable cells from cell and tissue debris, the length of time the cells are ex vivo and the temperature and nature of the media in which the cells are extracted.
Current procedures use a multi-stage approach to remove cells from fatty tissue. To isolate fatty cells, the cells are extracted mechanically with and through a cannula from the liposuction site and are drawn into the lumen of, e.g., a 5 or 10 ml syringe. Vacuum pressure to the cells is provided by pulling the syringe plunger. Next, the cannula is removed and the entire syringe is fitted with, e.g., a specialized Luer-Lock® attachment with a rounded surface opposite the attachment point that provides a rounded surface for insertion into, and centrifugation by, a centrifuge. The cells are then centrifuged and the viable cells are isolated from within the lumen of the syringe by transferring the cells from the syringe used for removal into a re-insertion syringe. In addition, one or more centrifugation and/or wash steps may be included before re-insertion of the fatty cells.
Accordingly, there is a need for a disposable liposuction device and method that provides for decreased cost of fabrication necessary to justify using the device for just one procedure. The device must also be easy to use with current surgical equipment, methods and techniques, reduce the ex vivo time of the cells and reduce the handling and transfer of cells between vessels. Finally, the device must provide a higher percentage of viable cells for transfer, reduction in the amount of cellular debris and provide easy visualization of the status of the tissue and cells.